Ma Antibodies a Monoclonal, kuchokera ku sayansi mpaka kupanga kupanga ndi TECNIC's Biotech Solutions

Mu 1986, United States Food and Drug Administration (US FDA) adavomereza woyamba monoclonal antibody therapy, ndipo kuyambira pamenepo, gawo la uinjiniya wa antibody lasintha kwambiri, popeza ma monoclonal antibodies (mAbs) akuyimira kupita patsogolo kwakukulu mu sayansi ya zamankhwala ndipo amagwira ntchito yofunika kwambiri njira zamakono zamankhwala. M'badwo wamakono wa mankhwala oteteza ma antibody ukuwonetsa kutsimikizika kwakukulu, zomwe zimapangitsa kuchepa kwakukulu kwa zovuta. Chifukwa chake, ma antibodies achire adatuluka ngati gulu lalikulu pakati pa mankhwala omwe angopangidwa kumene pochiza matenda osiyanasiyana amunthu, kuphatikiza khansa, automatenda a chitetezo chamthupi, mikhalidwe ya metabolic ndi matenda.

Poganizira zovuta za mAb biotech, ndikofunikira kukulitsa mtundu ndi kuchuluka kwa zomwe zimapangidwa. TECNIC mayankho, ndikudzipereka kuti asinthe limodzi, amapereka zida zomwe zimapangidwira kuti zikuthandizeni kukwaniritsa chitukuko chanu cha antibody monoclonal. athu upstream bioreactors ⇀ adapangidwa kuti akweze ndi kukhathamiritsa kupanga ma antibody a monoclonal, kuwonetsetsa kuti zokolola zimachulukira. Komanso, machitidwe athu a Tangential Flow Filtration , Yopangidwira downstream kuyeretsa, kupereka mosavuta ndi automatic sitepe yoyeretsa mAb yomwe mukufuna.

kufufuza TECNIC ndipo lolani mayankho athu atsogolere kukulitsa kwanu kwa monoclonal mAb.

Kodi antibodies monoclonal ndi chiyani?

Ma antibodies a monoclonal (mAbs) ndi mapuloteni opangidwa ndi labotale omwe amagwira ntchito mofanana ndi ma antibodies a chitetezo chamthupi ndipo, motero, amapangidwa kuti azindikire, kumanga ndi kuchititsa kuti chitetezo cha mthupi chitetezeke pamene akukumana ndi mabakiteriya, mavairasi, bowa, maselo a chotupa, allergens, poizoni kapena poizoni wina. Ma antibodies opangidwa ndi labotalewa adapangidwa kuti azikhala achindunji, ndipo mawonekedwe ake amawapangitsa kukhala ofunikira pakuzindikiritsa matenda ndi kuchiza.

Chithandizo cha monoclonal antibody ichi ndi chitsanzo chabwino chamankhwala amakono, opangidwa kuti azikhala okhazikika komanso otengera matenda enaake. Kukhala patsogolo pazochizira zamunthu m'malo monga hematology, immunology, oncology ndi matenda opatsirana ndikuchepetsa zotsatira zoyipa zomwe zimagwirizanitsidwa ndi njira zamankhwala azikhalidwe.

Chithandizo cha monoclonal antibody imapereka kutsimikizika kwakukulu komanso kumveka bwino pamene kuchepetsa zotsatira zoyipa poyerekeza ndi ochiritsira ochiritsira. Kusintha kwa kupanga ma antibody a monoclonal, kuchokera ku njira za hybridoma kupita ku matekinoloje ophatikizanso a DNA, sikunangowonjezera luso lawo lachirengedwe komanso kukulitsa ntchito yawo pakufufuza ndi kufufuza.

Kugwiritsa ntchito ma antibodies a monoclonal

Ma antibodies a monoclonal ndi ma immunoglobulins omwe amagwiritsidwa ntchito mobwerezabwereza m'magawo angapo, chifukwa ali ndi njira zingapo zochiritsira zomwe zingatheke pochiza matenda. mphumu, automatenda a chitetezo cha mthupi, khansa, poyizoni, septicemia, kugwiritsa ntchito mankhwala osokoneza bongo, matenda opatsirana ndi mavairasi, ndi matenda ena. Kuphatikiza apo, akhala ofunikira osati pakuwunika thanzi komanso kafukufuku, komanso kupewa kuwononga zakudya komanso kufufuza kuwononga chilengedwe.

Zitsanzo zina za ntchito ndi izi:

Ma antibodies a monoclonal mu chithandizo cha khansa ndi kafukufuku

Njira zodziwira matenda

Ntchito zina zachipatala

Zovuta pakupanga ma antibodies a monoclonal

Kuyambira pomwe antibody yoyamba ya monoclonal idavomerezedwa mu 1986, uinjiniya wa antibody wasintha kwambiri. Pamene kumvetsetsa kwathu kwa matenda kukukulirakulira, kuthekera kwa mankhwala a monoclonal antibody kumakula. Tawona chisinthiko kuchokera ku murine kupita ku ma antibodies aumunthu mu zomwe zakhala zoyesayesa zopambana zowonetsera bwino kwambiri zizindikiro za ma antibodies omwe amapezeka mwachibadwa. Chifukwa cha izi, Ma antibody omwe alipo tsopano amakhala ndi zotsatirapo zochepa kwambiri chifukwa cha kuchuluka kwawo, zomwe zawapanga m'zaka zaposachedwapa kukhala gulu lalikulu la mankhwala atsopano opangidwa.

Komabe, ngakhale izi zakwaniritsidwa bwino, kupanga ma antibodies a monoclonal (mAbs) kumakumanabe ndi zovuta ndi zovuta zina zomwe zimafunikira kafukufuku wopitilira komanso luso laukadaulo:

mAbs expression system

Zokolola ndi khalidwe; zovuta zowonjezera

Kuthana ndi zovuta zoyeretsa

Advanced Bioreactors

Pachitukuko chogwira ntchito cha bioprocess, kusunga ndalama zogulira, kukhalabe ndi zomwe mukufuna ndikuchepetsa nthawi yopanga, komanso kupereka kusinthasintha kwa kupanga ndizovuta kwambiri pamsika wamakono wamakono wa mabs. Kuphatikiza apo, kuti apange milingo yayikulu ya ma antibody kwa nthawi yayitali, pamafunika kukhathamiritsa zinthu zosiyanasiyana, kuphatikiza ma cell, media media, chikhalidwe, komanso kumvetsetsa bwino momwe zikhalidwe zimagwirira ntchito pamiyeso yosiyanasiyana, kuti zithandizire kuwongolera bwino. kukulitsa ndi kuyeretsa sitepe.

TECNIC Ma bioreactors ndiye njira yoyamba yopangira bwino komanso yolimba ya ma antibodies a monoclonal. Zathu upstream bioreactors eLAB®, ePILOT® ndi ePROD® zidapangidwa mwaluso kuti zizitha kuyang'anira momwe chilengedwe chimayendera, kukhathamiritsa ma cell kuti azitha zokolola zambiri ndikuchepetsa kugwiritsa ntchito nthawi. Kuwongolera komweku komanso kuyeza kolondola ndi zenizeni zenizeni kuchokera kwathu automatic control unit PLC imakupatsani mwayi wosintha zikhalidwe zomwe zimafunikira kuti mukwaniritse zotsatira zobwerezabwereza komanso zosasinthika. Sankhani magawo omwe mukufuna - kutentha, pH, kuthamanga kwa chipwirikiti, kuchuluka kwa gasi, O2 ndi CO2 yosungunuka, kuthekera kwa redox, kuchuluka kwa ma cell komanso kutheka - ndikupanga magwiridwe antchito osavuta a bioprocess.

Kuphatikiza apo, ngakhale ma cell a mammalian nthawi zambiri amaonedwa kuti ndi ovuta kukula chifukwa cha chidwi chawo pazochitika za physico-chemical, TECNIC's chibadidwe scalability ndi kusinthika kwa zida zathu kuonetsetsa bwino lonse-mmwamba ndondomeko ndi automatic control system ndi ma aeration oyenerera ndi ma agitation system. Kaya mukuchita upainiya kapena mukuyendetsa ntchito yopanga mafakitale, tithandizeni kuti tikwaniritse zosowa zanu zama antibodies apamwamba kwambiri a monoclonal.

Zida za Tangential Flow Filtration za ma antibodies a monoclonal

Mukafika gawo lomaliza la chikhalidwe cha bioreactor, ndikofunikira kupeza chomaliza chabwino cha mAb. Zotsogola downstream Zida za Tangential Flow Filtration za TECNIC amalekanitsa bwino anti-anti-antibody ku zonyansa ndi zonyansa, kuonetsetsa kuti pakhale chiyero chapamwamba chokhala ndi maulendo othamanga kwambiri. Komanso, chifukwa chake kwathunthu automatic system ndi zosankha zake zosiyanasiyana, eLAB® TFF ⇀, ePILOT® TFF ⇀ ndi ePROD® TFF ⇀ thandizirani kuchiyero chomaliza cha bioprocess yanu yonse ndi sitepe yosavuta.

TECNICMakina a TFF adapangidwa mwaluso kwambiri kuti akwaniritse zofunikira pakubweza kwazinthu za bioprocessing, ndikupereka chiyeretso chapamwamba pamitundu yosiyanasiyana yaukadaulo. Zida zathu zosefera zimatha kuthandizira ndikuwongolera magwiridwe antchito anu onse a bioprocesses. Kupereka mayankho odalirika a kusefedwa, kuphatikiza kuthamanga kwachulukidwe komanso kusungika kwakukulu kwa solute, mawonekedwe athu apamwamba amapangidwa kuti akhale abwino kwambiri. downstream processing wa mAbs. Komanso, wathu patsogolo automachitidwe a matic amapereka chidziwitso chosavuta kugwiritsa ntchito pamasikelo osiyanasiyana ogwirira ntchito, kuwonetsetsa kuti zotsatira zake zimakhala zokhazikika komanso zokhazikika.

Kuyesetsa pang'ono mu sterility ndikuyeretsa bioprocesses

TECNIC zida zimapangidwa kuchokera kuzitsulo zosapanga dzimbiri za AISI 304 ndi 316L, kotero mayankho athu onse amapangidwa ndi zida zapamwamba kwambiri, zopatsa zokolola zosayerekezeka pama labotale ndi masikelo amakampani. Kuphatikiza apo, pomvetsetsa kuti bizinesi iliyonse ili ndi zofunikira zapadera zoyeretsera, timapanganso zosankha zonse automatic ndi Yosavuta kugwiritsa ntchito ePLUS® CIP dongosolo ⇀, yomwe ndi njira yatsopano yolumikizirana yomwe imakhala ndi recipes ndi njira zambiri zomwe mungasinthire makonda kuti zikwaniritse zosowa zapadera m'malo opangira bioprocessing. Wokhoza kusamalira ntchito zoyeretsera zida voliyumu mpaka malita 2000, the ePLUS® CIP zimatsimikizira zotsatira zosasinthika, zapamwamba zokhala ndi chidziwitso chokonzekera mwachidziwitso, kuwonjezera mphamvu ndi kuchepetsa nthawi yochepetsera malo akuluakulu opangira bioprocessing.

Komabe, makasitomala ena amakonda kugwiritsa ntchito ma bioreactors Ogwiritsa Ntchito Kamodzi, chifukwa amalola kutsimikizika kosavuta kwa bioprocess ndipo amafuna kuyeserera pang'ono pankhani ya sterility ndi kuyeretsa. Pachifukwa ichi, m'malo omwe akukula mwachangu a Biotech, zatsopano Ntchito Imodzi eBAG® of TECNIC ⇀ imakweza zoyeserera zanu za bioprocess ndi magwiridwe antchito, mawonekedwe, kulimba komanso kuphweka. Yopangidwa ndi kupangidwa mkati TECNIC ISO7 Chipinda Choyera (Njira Yotsiriza-Kumapeto) ndipo yomangidwa ndi zida zolimba, zapamwamba kwambiri, zinthuzi zimakhala ndi mpweya wa gamma, womwe umawapangitsa kukhala okonzeka kugwiritsidwa ntchito molingana ndi miyezo yolimba kwambiri yamakampani azamankhwala.

Zopezeka mumitundu yosiyanasiyana, zitha kulowetsedwa mwachangu m'malo opangira ma labotale komanso opanga popeza kukhazikitsa, ziyeneretso ndi maphunziro a anthu ogwira ntchito ndizochepa. Komanso, SU eBAG® ikhoza kuonjezera mphamvu ya zomera ndi kusinthasintha mwa kuchepetsa nthawi yosinthira, makamaka ngati zitawonongeka, ndi kuchepetsa nthawi yoyimitsa. Kukhazikitsa zosintha zamapangidwe kumakhalanso kofulumira kwambiri ndi SU yotayika eBAG®, kulola kuwongolera kosalekeza ndi kuphatikiza kwa matekinoloje atsopano monga machitidwe owunikira pa intaneti. Ponseponse, maubwinowa amabweretsa kutsika mtengo kwachuma komanso zofunikira zotsika, zomwe ndizofunikira kwambiri kwamakampani akulu ndi ang'onoang'ono chimodzimodzi.

Nkhani zopambana ndi kugwiritsa ntchito

Ngakhale sitingathe kupereka zambiri chifukwa chachinsinsi, pakhala pali zochitika zambiri TECNICZipangizo zamtunduwu zathandizira kwambiri kupanga ma antibodies a monoclonal. Makasitomala athu adayika chidaliro chawo mwa ife, ndi kupambana kwa TECNIC mayankho amatsimikizira kupambana kwathu ndi kudzipereka kwathu kuti tisinthe limodzi.

Mwachitsanzo, pankhani yachitukuko chatsopano cha matenda odziwika bwino a odwala, m'modzi mwamakasitomala athu amafuna kulola zipatala kuti zitheke. sinthani zitsanzo zamagazi a odwala ndi kuphatikiza kusanthula kwa cytometry ndi ma antibodies a monoclonal. Pakuwunika kwawo kwa in vitro, adafunikira Kukulitsa kupanga chimodzi mwazochita zawo zofufuza (pogwiritsa ntchito eLAB® Advanced ⇀ monga bioreactor). Pamene amafunitsitsa kupanga zochulukirapo za IgM yofunikira, adagula imodzi ePILOT® BR ⇀ Ndi chimodzi ePILOT® TFF, kudalira TECNIC miyezo yovomerezeka yaubwino ndi kulimba kwa bioprocess.

Kusintha TECNIC mayankho a biotech, adatha kukhathamiritsa mawonekedwe a ma cell awo, zomwe zimapangitsa kuti pakhale zokolola zambiri za mAbs. Pambuyo pake, kugwiritsa ntchito ePILOT® TFF, kasitomala uyu adatha kuyeretsa mamAbs ofunikira pazamankhwala awo. Zotsatira zake, zolinga zawo zopanga zidakwaniritsidwa ndikuchita bwino kwambiri komanso kukhala ndi zotsatira zabwino kwambiri. Kuphatikiza apo, kudzipereka kwathu kumapulojekiti amakasitomala kumatsimikizira kuti timakhala osinthika pazomwe zikuchitika kapena thandizo lina lililonse lomwe lingafunike, ndipo pakadali pano, tikuperekabe chithandizo mosalekeza ndikukhala otanganidwa ndi polojekitiyi.

M'gawo lazamankhwala, TECNIC imagwiritsidwa ntchito kuti gwirizanani ndi makampani omwe amayang'ana kwambiri kupanga zinthu zazikulu za biotech pharma monga ma antibodies a monoclonal, mankhwala oletsa khansa, ma cell therapy, ndi zina. Izi zotsogola zamankhwala ndi biotechnology nthawi zambiri zimafuna kugwiritsa ntchito ma bioreactors upstream ndondomeko ndi downstream ma tangential filtration systems kuti atsimikizire zokolola zabwino, chiyero, ndi scalability. 

Mwachitsanzo, TECNIC panopa akukhudzidwa kwambiri ndi a pulojekiti yayikulu yopanga zanyama ya Chlamydia yowunikira matenda. Muzoyeserera zasayansi iyi, zathu ePROD® zida zimagwira ntchito yofunika kwambiri, kupereka kulondola komanso kuwongolera bwino kwa bioprocess kuti zitsimikizire zokolola zambiri za mAbs zomwe zikuyembekezeredwa pulojekitiyi. Pambuyo pake, athu ePROD® TFF amalekanitsa bwino anti-anti-anti-anti-anti-anti-anti-anti-antibody omwe amachokera ku chikhalidwe cha media ndi zonyansa zina. Izi zimatha ndi kuyera kwakukulu kophatikizana ndi zokolola zabwino, zomwe ndi umboni wa kudzipereka kwathu pakupambana kwamakasitomala.

Onani zida zathu zonse

Ma bioreactor athu adapangidwa kuti azigwiritsidwa ntchito mosiyanasiyana, kuwonetsetsa kuti zikuyenda bwino komanso zabwino. Dziwani zambiri zamayankho athu asayansi yazachilengedwe, kuphatikiza ma Bioreactors, Tangential Flow Filtration system, ndi zina zambiri. Pitani patsamba lathu kuti mumve Ma bioreactors ⇀, Kusefera kwa Tangential Flow ⇀ndipo Lumikizanani ndi ⇀ kuti apitirize information ndi kufunsa.